Evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser for HbA1c.

ABSTRACT

BACKGROUND: We report an evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser (HA-8180V), the fifth generation Menarini/ARKRAY ion-exchange HPLC for the measurement of HbA(1c). METHODS: We evaluated the analytical performance, the measurement of haemoglobin variants and the performance in comparison to major analytical methods. RESULTS: Within-run, between-run and total CV were 0.2%, 0.4% and 0.7% at low HbA(1c) concentrations and 0.2%, 0.2% and 0.4% at high HbA(1c) concentrations, respectively. Trueness revealed a maximum deviation of 0.8 mmol/mol (IFCC units) or 0.1% (NGSP units) over the relevant analytical range. Linearity, carry-over and linear drift were excellent. Labile-HbA(1c), carbamylated haemoglobin, icteric samples and variation in hematocrit did not affect HbA(1c) outcome. Haemoglobin variants AS, AC and F do not affect HbA(1c) outcome and are explicitly identified and correctly quantified. HbA(1c) can not be measured in samples with AE and AD, but these variants are identified correctly. In comparison to other methods used at present, the HA-8180V shows excellent performance. CONCLUSIONS: The HA-8180V performs at a high level and is fit for any clinical application.